BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    EQUALSHIELD LUER LOCK CONNECTOR PAIR

    K Number: K091389 · Decision Oct 22, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    2
    Review Days
    164

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    Basic Information

    Device Name
    EQUALSHIELD LUER LOCK CONNECTOR PAIR
    K Number
    K091389
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Plastmed, Ltd.
    Date Received
    May 11, 2009
    Decision Date
    October 22, 2009
    Product Code
    LHI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LHI Set, I.V. Fluid Transfer

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    Other Clearances by Plastmed, Ltd.

    K Number Device Name
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